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HealthyPhase 2NCT03223649

Break It Up: A Study Evaluating Breaking Up Daily Sedentary Behavior in Youth

A Phase 2 study testing Walking Bouts and Sedentary in people with Healthy and Obesity, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Some studies have found that people can better process sugars when they take walking breaks. Studies have also found that children's attention and memory may improve after exercise. It is not known if short walking breaks have the same effects. Read more about this study

Who is it for?
Ages 7 to 11 years
Conditions the study is for
Healthy, Obesity, Overweight
What is being tested?
Walking Bouts and Sedentary
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
1 siteUnited States
Study dates
26 Jul 2017to 23 Feb 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Participants will qualify for the study if they meet the following criteria:
  • Good general health.
  • Age greater than or equal to 7 and less than 12 years.
  • Fasting plasma glucose less than 100 mg/dL
  • Body mass index (BMI) greater than or equal to the 5th percentile, as determined by the CDC age- and sex- specific growth charts.
  • Participants will qualify for the study if they qualify for the primary Break It Up! study.

Who cannot join

  • Participants will be excluded from the study for:
  • Significant cardiac or pulmonary disease likely to or resulting in hypoxia or decreased perfusion.
  • Evidence of impaired glucose tolerance or type 2 diabetes, including fasting plasma glucose greater than or equal to 100 mg/dL.
  • Presence of other endocrinologic disorders leading to obesity (e.g.: Cushing Syndrome).
  • Participants who have, or whose parent/guardians have, current substance abuse or a psychiatric disorder or other condition that, in the opinion of the investigators, would impede competence, compliance, or prevent the completion of the study.
  • Participants who have, or are currently receiving, anti-psychotic drugs that would affect metabolism, cognitive outcomes, and body habitus.
Show all 30Show fewer
  • Participants receiving medical treatment other than diet for hypertension or dyslipidemia.
  • Participants with precocious puberty and/or receiving androgen and estrogen therapy.
  • Participants currently taking medications for ADHD, or any disorder or use of medications known to affect body composition or weight including but not limited to glucocorticoids or other steroid compounds.
  • Presence of pre-existing neurocognitive disabilities, or an age-adjusted score below 85 on the Picture Vocabulary Test at the screening visit.
  • Presence of food allergies, such as peanut/tree nut, dairy, soy or any other food allergy or personal dietary restrictions that would preclude participant from consuming the daily diet or the buffet.
  • Presence of significant skin disease or allergy to adhesive material prohibiting placement of a continuous glucose monitor.
  • Participants unable or unwilling to abstain from acetaminophen, ascorbic acid, or salicylic acid during study duration.
  • Participant does not speak fluent English.
  • Participant is or becomes pregnant.
  • Participant has an ambulatory impairment
  • OPTIONAL MRS SUPPLEMENTAL ARM
  • Cannot have MRI scanning. Some of the reasons a child might not be able to have MRI include:
  • Implanted cardiac pacemaker or defibrillator
  • Cochlear Implants
  • Ocular foreign body (e.g. metal shavings)
  • Embedded shrapnel fragments
  • Central nervous system aneurysm clips
  • Implanted neural stimulator
  • Medical infusion pumps
  • Any implanted device that is incompatible with MRI.
  • Is not likely to tolerate an MRI scan. Examples of medical conditions that would make it difficult to undergo MRI include severe anxiety (nervousness) or hyperactivity which make it hard for your child to lay flat for the study.
  • Requires sedation for MRI studies.
  • Has a condition that makes entry into the scanner difficult (e.g. weight over 550 lbs, claustrophobia, etc.).
  • Has severe back-pain or motion disorders that make it hard for a child to lie on his/her back within the MRI scanner and hold still for the scan.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Background:

Some studies have found that people can better process sugars when they take walking breaks. Studies have also found that children's attention and memory may improve after exercise. It is not known if short walking breaks have the same effects. Researchers want to study if breaking up sitting with walking for 6 days helps children s bodies use sugars and improves concentration.

Read more

Objectives:

To learn if breaking up sedentary (low-activity) time with short walking breaks over 6 days affects how children s bodies use sugar. To learn if breaking up sedentary time changes children s attention, memory, feelings, activity, or eating.

Eligibility:

Children ages 7-11 in general good health

Design:

Participants will be screened with:

  • Medical history
  • Physical exam
  • Fasting blood tests. On 2 out of 7 total study visits, participants cannot eat or drink after 10 p.m. the night before.
  • Full-body X-ray
  • EKG (Electronic signals that record heart function through stickers)
  • Treadmill exercise. Heart, blood pressure, and oxygen will be monitored.
  • Questions about the child s health, socialization, and activity, and parent s education and economic status
  • Picture vocabulary test
  • Dietician meeting (Questions about eating habits)

Participants will have visits on 6 consecutive days. Over that time, they will wear 2 devices to monitor blood sugar and activity (even while at home).

Participants will have 5 after-school visits. These include:

  • Health check
  • Snack plus food for the next 24 hours
  • Activity monitored
  • 3-hour sitting tests. Participants will do non-active things. Some will have 3-minute walks every 30 minutes.
  • Cognitive tests and questions about mood and anxiety are given on days #1 \& 5.

Participants will fast before the last visit in the morning. They will have:

  • 9 blood draws by IV catheter. Participants will drink sugar water.
  • Sitting test
  • Activity monitored
  • Meal (food buffet)
Read the detailed description

Background:

Sedentary behavior is defined as a set of low-intensity activities involving limited body movement (e.g.: TV viewing, prolonged sitting). Some studies have found higher levels of childhood sedentary behavior predict higher body mass index (BMI) and metabolic abnormalities. We and others have found that interrupting sitting with short, 2-3 minute bouts of moderate activity (walking) can improve glucose tolerance during a single session. Thus, interrupting sedentary behavior may be an intervention strategy to reduce health risks.

Objective:

We propose to conduct a randomized pilot study to assess whether interrupting sedentary behavior for 6 consecutive days provides sustained improvement in carbohydrate metabolism without negatively impacting executive function, attention, mood, anxiety, dietary

intake or usual physical activity.

Design \& Population:

Using a randomized parallel group design, children, ages 7-11 years, will complete an assigned randomized condition of either 6 consecutive days of 3 hours of monitored sedentary activity (sitting) or 6 consecutive days of 3 hours of interrupted sitting (in which they will be prompted to walk for 3 minutes every 30 minutes).

Outcome measures:

Twenty-four-hour continuous glucose monitoring and postprandial insulin incremental area under the curve (iAUC) on post-condition oral glucose tolerance testing will be the primary measures. Secondary measures include: postprandial glucose iAUC, executive function, attention, mood, anxiety, dietary intake, and free-living physical activity.

Impact:

This project will investigate if consecutive daily interruption of sitting behaviors improves glucose tolerance, a potential negative health consequences of sedentary behavior in children. If repeatedly interrupting sitting with short bouts has sustained beneficial effects among children, interventions examining the frequency, duration, and intensity of such interruptions could be developed for use in the community setting. Thus, these results have the potential to provide insight into novel behavioral intervention targets in youth.

Being tested
Walking Bouts, Sedentary
Keywords
Metabolism, Children, Walking Bouts, Glucose, Insulin
Medical subject headings
Obesity, Overweight, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Walking BoutsOther

    Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test.

  • SedentaryOther

    (Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.

Study groups in NCT03223649
Study groupRoleWhat they receive
SedentaryExperimental(Control intervention) Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.
Receives: Other: Sedentary
Walking boutsExperimentalSix daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test.
Receives: Other: Walking Bouts

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insulin iAUC Obtained During the Oral Glucose Tolerance Test at the Final Experimental Visit.

    Insulin integrated area under the curve (iAUC) as a marker of glucose metabolism on OGTT during test day #6, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion

    Measured: test day 6

Secondary outcomes (9)

  1. Glucose iAUC Obtained During the Oral Glucose Tolerance Test on Day # 6 of Intervention.

    Integrated area under the curve (iAUC) for glucose values during the oral glucose tolerance test, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion

    Measured: test day 6

  2. C-Peptide iAUC Obtained During the Oral Glucose Tolerance Test on Day # 6 of Intervention.

    Integrated area under the curve (iAUC) for C-Peptide values during the oral glucose tolerance test, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion

    Measured: test day 6

  3. Free Fatty Acid iAUC Obtained During the Oral Glucose Tolerance Test on Day # 6 of Intervention.

    Integrated area under the curve (iAUC) for Free Fatty Acid values during the oral glucose tolerance test, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion

    Measured: test day 6

  4. Daily Physical Activity (Step Counts/Min) During Intervention.

    Mean 3-dimensional activity during the 3 hours of intervention from all days (step counts per minute)

    Measured: test days 1-6

  5. Daily Physical Activity (3-dimensional Activity Counts/Day) Outside of the Intervention.

    Mean total daily 3-dimensional activity counts during the 21 hours without intervention on days 1-6 (activity counts/21 hours) from triaxial write accelerometers worn at home. Note: these are not "step counts" but total 3D activity counts because motion of the wrist at times other than walking are also recorded. There is no simple way to convert these counts to step counts.

    Measured: test days 1-6

  6. Energy Intake at the Final Test Meal.

    Total energy intake (kcal) during buffet meal immediately after the end of intervention

    Measured: test day 6

  7. Percentage Fat Intake at the Final Test Meal.

    Percentage Energy intake from Fat during buffet meal immediately after the end of intervention

    Measured: test day 6

  8. Percentage Carbohydrate Intake at the Final Test Meal.

    Percentage Energy intake from Carbohydrate during buffet meal immediately after the end of intervention

    Measured: test day 6

  9. Percentage Protein Intake at the Final Test Meal.

    Percentage Energy intake from Protein during buffet meal immediately after the end of intervention

    Measured: test day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2017
  2. Study start26 Jul 2017
  3. Primary completion26 Jun 2020
  4. Study completion23 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03223649
Sponsor's protocol ID
170130
Other IDs
17-CH-0130
Status last verified
4 Jan 2021
First submitted
19 Jul 2017
Last updated
11 Jun 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual level deidentified data for all sociodemographic characteristics and outcomes will be made available after publication of the study primary outcome.

Publications

  • Broadney MM, Belcher BR, Berrigan DA, Brychta RJ, Tigner IL Jr, Shareef F, Papachristopoulou A, Hattenbach JD, Davis EK, Brady SM, Bernstein SB, Courville AB, Drinkard BE, Smith KP, Rosing DR, Wolters PL, Chen KY, Yanovski JA. Effects of Interrupting Sedentary Behavior With Short Bouts of Moderate Physical Activity on Glucose Tolerance in Children With Overweight and Obesity: A Randomized Crossover Trial. Diabetes Care. 2018 Oct;41(10):2220-2228. doi: 10.2337/dc18-0774. Epub 2018 Aug 6.

    PubMed 30082324

  • Belcher BR, Berrigan D, Papachristopoulou A, Brady SM, Bernstein SB, Brychta RJ, Hattenbach JD, Tigner IL Jr, Courville AB, Drinkard BE, Smith KP, Rosing DR, Wolters PL, Chen KY, Yanovski JA. Effects of Interrupting Children's Sedentary Behaviors With Activity on Metabolic Function: A Randomized Trial. J Clin Endocrinol Metab. 2015 Oct;100(10):3735-43. doi: 10.1210/jc.2015-2803. Epub 2015 Aug 27.

    PubMed 26312582

  • Dunstan DW, Kingwell BA, Larsen R, Healy GN, Cerin E, Hamilton MT, Shaw JE, Bertovic DA, Zimmet PZ, Salmon J, Owen N. Breaking up prolonged sitting reduces postprandial glucose and insulin responses. Diabetes Care. 2012 May;35(5):976-83. doi: 10.2337/dc11-1931. Epub 2012 Feb 28.

    PubMed 22374636

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Walking Bouts and Sedentary in people with Healthy and Obesity, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin iAUC Obtained During the Oral Glucose Tolerance Test at the Final Experimental Visit. (time frame: test day 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03223649, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.

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Clinical Trial NCT03223649 | AzTrials